MHRA Offers Roadmap for Reporting Drug Defects

The UK’s Medicines and Healthcare products Regulatory Agency (MRHA) is reminding drugmakers they must report all defects in medicinal products that could lead to a recall immediately upon discovery and provide regular updates on internal investigations into the defects.

The reporting obligation is sometimes overlooked and frequently confused with adverse event reporting requirements, but in fact, defects require a separate report and are governed by a separate regulatory body, the Defective Medicines Report Centre (DMRC), according to new guidelines the agency has produced to instruct companies about how to report defective products.

The report from the company is the trigger that starts discussions between the manufacturer and the DMRC about whether to implement a recall, and the urgency of the recall. While the MHRA can impose recalls if it discovers defective medicines on its own, it prefers to use the reporting process to work collaboratively with companies.

Initial reports to the DMRC should include the following information:

• Dates of drug manufacture and release to the market;
• An impact assessment quantifying the number of batches affected;
• Where admixture has occurred, dates of manufacture and release of the admixed product, closest to the complaint batch;
• Batch and pack sizes;
• Date of first and last distribution to the market;
• Review of complaint records for reports of similar defects;
• Estimation of stock; and
• Information on the same batch being distributed to other countries.

Following the initial report, drugmakers must provide regular updates on the progress of their investigations, and a final report should be provided no more than 12 weeks after the initial report.